EN ISO 16021:2024 PDF

Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers (ISO 16021:2024)

Title (English):

EN ISO 16021:2024

Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers (ISO 16021:2024)

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 19
Publication date:: April 3, 2024
Edition:: CEN EN 16021 edition 2 version 1
ICS:: 11.180.20

Document language:

enru

Delivery time:1–7 days

Price:66 €

Description (English):

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements on creating data collection tools. In particular, it provides a framework for eliciting and recording the views of users and their carers on the acceptability of products. In addition, a product diary is described which can help to quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product and the severity of any leakage from it. This document does not cover direct comparison between products based on statistical parameters, neither does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.

Technical details

Technical committee: CEN/TC 293 - Technical aids for disabled persons
SKU: EN ISO 16021:2024

Abstract

Overview

EN ISO 16021:2024 - "Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers" - provides guidance for planning and conducting user-centred evaluations of single‑use, body‑worn adult absorbent incontinence products. The standard focuses on eliciting and recording the views of users and caregivers and describes practical data‑collection tools, including a product diary to quantify parameters such as wear time, mass of urine absorbed and severity of leakage. It does not prescribe statistical product comparisons or clinical efficacy testing (see ISO 14155 for clinical investigations).

Key topics and requirements

Evaluation protocol design: Guidance on creating repeatable, ethical user-evaluation protocols and data collection plans.
Questionnaires and data tools: Requirements for developing product evaluation questionnaires and structured data‑gathering instruments targeted at users and caregivers.
Product diary: A standardized diary format to record key use parameters (wear times, absorbed mass, leakage events) to support practical, quantitative observation.
Participant selection: Considerations for selecting products, user groups and caregivers, and defining an appropriate evaluation period.
Pilot studies and preparations: Recommendations to validate questionnaires and procedures before full trials.
Data collection and reporting: Clear sections for demographic data, product performance data, user withdrawal tracking and producing a comprehensive evaluation report.
Ethics and harmonization: Notes on ethics committee approval where required and terminology harmonized with related ISO standards (e.g., ISO 22748).

Practical applications

This standard is practical for:

Manufacturers and product designers conducting usability and acceptability testing during product development.
Clinical researchers and usability teams running user‑based trials focusing on acceptability and user/caregiver feedback.
Procurement and healthcare providers assessing suitability of products for specific patient groups.
Regulatory and quality teams documenting user-evaluation methods as part of post‑market surveillance or usability evidence.
Care organisations and caregivers seeking structured approaches to capture real-world product performance.

Related standards

ISO 14155 - Clinical investigations of medical devices (for clinical efficacy testing).
ISO 22748 - Related terminology alignment for assistive products.

EN ISO 16021:2024 helps standardize how user and caregiver perspectives are collected and documented for single‑use adult absorbent incontinence products, improving product development, procurement decisions and real‑world evidence collection.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and requirements

Evaluation protocol design: Guidance on creating repeatable, ethical user-evaluation protocols and data collection plans.
Questionnaires and data tools: Requirements for developing product evaluation questionnaires and structured data‑gathering instruments targeted at users and caregivers.
Product diary: A standardized diary format to record key use parameters (wear times, absorbed mass, leakage events) to support practical, quantitative observation.
Participant selection: Considerations for selecting products, user groups and caregivers, and defining an appropriate evaluation period.
Pilot studies and preparations: Recommendations to validate questionnaires and procedures before full trials.
Data collection and reporting: Clear sections for demographic data, product performance data, user withdrawal tracking and producing a comprehensive evaluation report.
Ethics and harmonization: Notes on ethics committee approval where required and terminology harmonized with related ISO standards (e.g., ISO 22748).

Practical applications

This standard is practical for:

Manufacturers and product designers conducting usability and acceptability testing during product development.
Clinical researchers and usability teams running user‑based trials focusing on acceptability and user/caregiver feedback.
Procurement and healthcare providers assessing suitability of products for specific patient groups.
Regulatory and quality teams documenting user-evaluation methods as part of post‑market surveillance or usability evidence.
Care organisations and caregivers seeking structured approaches to capture real-world product performance.

Related standards

ISO 14155 - Clinical investigations of medical devices (for clinical efficacy testing).
ISO 22748 - Related terminology alignment for assistive products.

EN ISO 16021:2024 PDF

Technical details

Abstract

Overview

Key topics and requirements

Practical applications

Related standards

Related standards

Abstract

Overview

Key topics and requirements

Practical applications

Related standards

Related standards

Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult…

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)

Absorbent incontinence products for urine and/or faeces - Product type names and illustrations (ISO 22748:202…